Smoking Cessation Clinical Trial
— VOTCOfficial title:
Varenicline OTC Trial on Efficacy and Safety
Verified date | April 2022 |
Source | Arizona State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary goal of the proposed research is to test whether varenicline (Chantix) is safe and effective as an over-the-counter (OTC) medication.
Status | Completed |
Enrollment | 307 |
Est. completion date | April 16, 2022 |
Est. primary completion date | April 16, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years and older |
Eligibility | Inclusion Criteria for the In-person Cohort 1. 21 years of age or older 2. Self-reported daily smoker 3. Breath CO > 10ppm 4. Motivated to quit smoking completely within five weeks of the Screening Visit (>5 on reported motivation) 5. Capable of and agree to complete study requirements 6. Literate in English, self-report 7. Must be available for the duration of study 8. Informed consent obtained 9. Willing and able to provide additional data between visits using ecological momentary assessment (EMA) 10. Must own study compatible smart-phone (iPhone or Android) Exclusion Criteria for the In-person Cohort 1. Any self-report, diagnosis or treatment of heart attack, unstable angina, angioedema, seizures, cerebrovascular accident (CVA) within the last six months. 2. Any self-report, diagnosis or treatment of bipolar, schizophrenia or suicidal ideation within the last six months. (For suicidal ideation a score of =7 on the Suicidal Behavior Questionnaire, see Appendix 15) 3. Self-report of diagnosis or treatment for depression within the past six months, unless participant has written permission by their healthcare provider to participate 4. Systolic blood pressure 160 or higher and/or diastolic blood pressure 100 or higher (see site applicable SOP for Evaluating and Reporting Blood Pressure and Appendices 5 and 6 for participant handouts) 5. History of renal disease 6. Allergy to any of the ingredients in varenicline 7. Participation in another smoking cessation program or any type of clinical trial in the past 3 months 8. Use of any smoking cessation medication in the past three months 9. Any other medical condition(s) which the licensed study physician deems unacceptable for participation in this study 10. Positive drug screen indicating possible substance abuse (eg opiates, amphetamines, benzodiazepines, cocaine or other substances), unless participant can show that the medication has been prescribed by licensed clinical provider. 11. Consume greater than 21 alcohol drinks per week. 12. No two members of the same household may participate in this study 13. No study staff or their immediate family may participate in the study 14. Females who are pregnant, breast feeding, or not currently using a medically approved form of birth control and unwilling to do so. Acceptable methods of birth control include abstinence, oral contraceptives, the contraceptive patch, the contraceptive ring, and condoms. Inclusion Criteria for the Remote Cohort 1. 21 years of age or older 2. Self-reported daily smoker 3. Positive cotinine from urine sample 4. Motivated to quit smoking completely within five weeks of the Screening Visit (>5 on reported motivation) 5. Capable of and agree to complete study requirements 6. Literate in English, self-report 7. Must be available for the duration of study 8. Informed consent obtained 10. Must own study compatible smart-phone (iPhone or Android) 11. Must be a current resident of the United States Exclusion Criteria for the Remote Cohort 1. Any self-report, diagnosis or treatment of heart attack, unstable angina, angioedema, seizures, cerebrovascular accident (CVA) within the last six months. 2. Any self-report, diagnosis or treatment of bipolar, schizophrenia or suicidal ideation within the last six months. (For suicidal ideation a score of =7 on the Suicidal Behavior Questionnaire, see Appendix 15) 3. Self-report of diagnosis or treatment for depression within the past six months, unless participant has written permission by their healthcare provider to participate 4. History of renal disease 5. Allergy to any of the ingredients in varenicline 6. Participation in another smoking cessation program or any type of clinical trial in the past 3 months 7. Use of any smoking cessation medication in the past three months 8. Any other medical condition(s) which the licensed study physician deems unacceptable for participation in this study 9. Consume greater than 21 alcohol drinks per week. 10. No two members of the same household may participate in this study 11. No study staff or their immediate family may participate in the study 12. Females who are pregnant, breast feeding, or not currently using a medically approved form of birth control and unwilling to do so. Acceptable methods of birth control include abstinence, oral contraceptives, the contraceptive patch, the contraceptive ring, and condoms. |
Country | Name | City | State |
---|---|---|---|
United States | Los Angeles Clinical Trials | Burbank | California |
United States | Arizona State University | Phoenix | Arizona |
Lead Sponsor | Collaborator |
---|---|
Arizona State University | Los Angeles Clinical Trials, National Institute on Drug Abuse (NIDA), Pfizer, University of Nevada, Reno |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Breath carbon monoxide verified abstinence from smoking cigarettes | Participants will provide self reported smoking status that has been verified by breath carbon monoxide | Week 12 | |
Secondary | Adverse events | Participants will be asked to report adverse events | Week 2 visit | |
Secondary | Adverse events | Participants will be asked to report adverse events | Week 4 visit | |
Secondary | Adverse events | Participants will be asked to report adverse events | Week 8 visit | |
Secondary | Adverse events | Participants will be asked to report adverse events | Week 12 visit | |
Secondary | Adverse events | Participants will be asked to report adverse events | Week 13 visit | |
Secondary | Adverse events | A subset of participants will be asked to report adverse events via ecological momentary assessment (EMA). EMA asks questions via the participant mobile phone on multiple occasions, primarily at random | Change in adverse events from baseline to week 2 as measured by 5 daily EMA prompts | |
Secondary | Withdrawal symptoms and craving | Participants will be asked to report withdrawal symptoms, as measured by the Minnesota Nicotine Withdrawal Scale (MNWS). Scores can be between 0 (absent) - 4 (severe), and the average scores will be assessed. | week 2 visit | |
Secondary | Withdrawal symptoms and craving | Participants will be asked to report withdrawal symptoms, as measured by the Minnesota Nicotine Withdrawal Scale (MNWS). Scores can be between 0 (absent) - 4 (severe), and the average scores will be assessed. | week 4 visit | |
Secondary | Withdrawal symptoms and craving | Participants will be asked to report withdrawal symptoms, as measured by the Minnesota Nicotine Withdrawal Scale (MNWS). Scores can be between 0 (absent) - 4 (severe), and the average scores will be assessed. | week 8 visit | |
Secondary | Withdrawal symptoms and craving | Participants will be asked to report withdrawal symptoms, as measured by the Minnesota Nicotine Withdrawal Scale (MNWS). Scores can be between 0 (absent) - 4 (severe), and the average scores will be assessed. | week 12 visit | |
Secondary | Withdrawal symptoms and craving | Participants will be asked to report withdrawal symptoms, as measured by the Minnesota Nicotine Withdrawal Scale (MNWS). Scores can be between 0 (absent) - 4 (severe), and the average scores will be assessed. | week 13 visit | |
Secondary | Craving | Participants will be asked to report craving via ecological momentary assessment (EMA). EMA asks questions via the participant mobile phone on multiple occasions, primarily at random | change in craving from baseline to week 2 as measured by 5 daily EMA prompts | |
Secondary | Breath carbon monoxide verified abstinence from smoking cigarettes | Participants who self report not smoking will be asked to have smoking status verified by breath carbon monoxide | Week 26 |
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